Ruxolitinib In GvHD (NCT02396628) | Clinical Trial Compass
TerminatedPhase 2
Ruxolitinib In GvHD
Stopped: impossibility to recruit in the BAT arm
Germany22 participantsStarted 2017-06-29
Plain-language summary
The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory aGvHD. In this phase 2 trial the efficacy of Ruxolitinib and best available treatment (BAT) versus BAT in steroid-refractory acute GvHD in approximately 12 transplantation centers in Germany will be compared. The response by monitoring the clinical GvHD grade, requirement of alternative GvHD active agents and serum levels of pro-inflammatory cytokines will be determined.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Acute skin, intestinal (histologically confirmed) or liver GvHD \> grade 1 according to standard criteria
✓. Age ≥18 years
✓. Failure of previous treatment, defined as presence of at least one of the following criteria:
✓. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and lack of response after at least 7 days treatment
✓. Treatment with prednisone/prednisolone/methylprednisolone in a dose of at least 2 mg/kg and progression after at least 3 days of treatment
✓. Failure to taper the prednisone/prednisolone dose to \<0.6 mg/kg/day or methylprednisolone dose to \<0.5 mg/kg/day
✓. Written informed consent
✓. Ability to understand the nature of the study and the study related procedures and to comply with them
Exclusion criteria
✕. Uncontrolled underlying disease
What they're measuring
1
efficacy of Ruxolitinib and BAT as compared to BAT alone at day 28 after randomisation